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Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance)
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The specific principles shall apply without prejudice to the general principles referred to in Section 1.
For each authorisation granted the [F1competent authorities] shall ensure that the micro-organism concerned is deposited at an internationally recognised culture collection and has an accession number. Each micro-organism must be identified and named at the species level and characterised at the strain level. There must also be information as to whether or not the micro-organism is a wild type or a spontaneous or induced mutant, or a genetically modified organism.
Textual Amendments
F1Words in Annex Pt. 2.C point 2.1 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xiii); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F2Words in Annex Pt. 2.C point 2.2.1 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xiv); 2020 c. 1, Sch. 5 para. 1(1)
No authorisation shall be granted unless full information is provided on the continuous quality control of the production method, production process and plant protection product. In particular, the occurrence of spontaneous changes in major characteristics of the micro-organism and the absence/presence of contaminating organisms shall be considered. The quality assurance criteria for production and the techniques used to ensure a uniform plant protection product must to the extent possible be described and specified.
Textual Amendments
F3Words in Annex Pt. 2.C point 2.4.1.4 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xv); 2020 c. 1, Sch. 5 para. 1(1)
Where proposed label claims include recommendations for use of the preparation with specified plant protection products or adjuvants as a tank mix, [F4competent authorities] shall not accept the recommendations unless they are justified.
Textual Amendments
F4Words in Annex Pt. 2.C point 2.4.1.5 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xvi); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F5Words in Annex Pt. 2.C point 2.4.1.6 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xvii); 2020 c. 1, Sch. 5 para. 1(1)
The methods proposed must reflect the latest techniques. Methods for post-authorisation monitoring shall involve the use of commonly available reagents and equipment.
plants, plant products, foodstuffs of plant and animal origin and feedingstuffs if toxicologically relevant residues occur. Residues are considered relevant if a maximum residue level (MRL) or a waiting or re-entry safety period or other such precaution is required;
soil, water, air and/or body tissues if toxicologically, ecotoxicologically or environmentally relevant residues occur.
When making a decision on the authorisation of the microbial plant protection product, [F6competent authorities] shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly through the environment and at work, and animals.
Textual Amendments
F6Words in Annex Pt. 2.C point 2.6.1.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xviii); 2020 c. 1, Sch. 5 para. 1(1)
Where the proposed conditions of use require use of items of protective clothing, no authorisation shall be granted unless those items are effective and in accordance with relevant [F7retained EU law], and are readily obtainable by the user and unless it is feasible to use them under the conditions of use of the plant protection product, taking into account climatic conditions in particular.
Textual Amendments
F7Words in Annex Pt. 2.C point 2.6.1.3 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xix); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F8Words in Annex Pt. 2.C point 2.6.1.9 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xx); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F9Words in Annex Pt. 2.C point 2.7.2 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xxi); 2020 c. 1, Sch. 5 para. 1(1)
the parameters or maximum permissible concentrations laid down by [F10the EU-derived domestic legislation which transposed] Directive 98/83/EC; or
the parameters or maximum permissible concentrations laid down for components in the plant protection product such as relevant metabolites/toxins in accordance with [F11the EU-derived domestic legislation which transposed] Directive 2000/60/EC; or
the parameters for the micro-organism or the maximum concentration laid down for components in the plant protection product such as relevant metabolites/toxins when approving the micro-organism in accordance with Regulation (EC) No 1107/2009, on the basis of appropriate data, in particular, toxicological data, or, where that concentration has not been laid down, the concentration corresponding to 1/10 of the acceptable daily intake (ADI) laid down when the micro-organism was approved in accordance with Regulation (EC) No 1107/2009,
Textual Amendments
F10Words in Annex Pt. 2.C point 2.7.3(a) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xxii); 2020 c. 1, Sch. 5 para. 1(1)
F11Words in Annex Pt. 2.C points 2.7.3(b), 2.7.4 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xxiii); 2020 c. 1, Sch. 5 para. 1(1)
unless it is scientifically demonstrated that under relevant field conditions the lower of the parameters or concentrations is not contravened or exceeded.
exceeds, where the surface water in or from the area of envisaged use is intended for the extraction of drinking water, concentrations above which compliance with drinking water quality established in accordance with [F11the EU-derived domestic legislation which transposed] Directive 2000/60/EC is compromised; or
exceeds the parameters or values for components in the plant protection product, such as relevant metabolites/toxins, established in accordance with [F11the EU-derived domestic legislation which transposed] Directive 2000/60/EC; or
has an impact deemed unacceptable on non-target species, including animals, in accordance with [F11the EU-derived domestic legislation which transposed] the relevant requirements provided for in point 2.8.
The proposed instruction for use of the plant protection product, including procedures for cleaning application equipment, must be such that the likelihood of accidental contamination of surface water is reduced to a minimum.
[F12Competent authorities] shall ensure that the available information is sufficient to permit a decision to be taken as to whether or not there may be unacceptable effects on non-target species (flora and fauna), due to exposure to the plant protection product containing the micro-organism following its intended use.
Textual Amendments
F12Words in Annex Pt. 2.C point 2.8 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xxiv); 2020 c. 1, Sch. 5 para. 1(1)
[F12Competent authorities] shall pay special attention to possible effects on beneficial organisms used for biological control and organisms playing an important role in integrated control.
the micro-organism is pathogenic to birds and other non-target terrestrial vertebrates;
in case of toxic effects due to components in the plant protection product, such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 10 on the basis of the acute LD50 value or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.
the micro-organism is pathogenic to aquatic organisms;
in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 100 in case of acute toxicity (EC50) to daphnia and fish and 10 for long-term/chronic toxicity to algae (EC50), daphnia (NOEC) and fish (NOEC), unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species occurs — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.
if the micro-organism is pathogenic to bees;
in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product in accordance with the proposed conditions of use.
the micro-organism is pathogenic to arthropods other than bees;
in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product in accordance with the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data.
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